PMA P140020S018
- Device
- BRACAnalysis CDx
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S018
- Product code
- PJG
- Decision date
- 2018-12-19
- Classification
- Cancer-related Germline Gene Mutation Detection System
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Approval for the BRACAnalysis CDx®, for gBRCA mutated ovarian cancer patients maintenance monotherapy with Lynparza® (olaparib).
Current openFDA PMA Record#
- Device
- BRACAnalysis CDx
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S018
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2018-12-19
- Decision code
- APPR
- Date received
- 2018-09-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the BRACAnalysis CDx®, for gBRCA mutated ovarian cancer patients maintenance monotherapy with Lynparza® (olaparib).